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Subject Matter Expert Biophysical Analysis (Associate Principal Scientist) Netherlands,
Posted on : 04 June 2017
- The Biologics & Vaccines Analytics (BVA) organisation supports the commercialization of vaccines and biotechnological derived pipeline products.
- Furthermore, BVA has a crucial role in supporting vaccines and biologics Lines of Business (LoB) and the Quality Organization.
- These teams are regionally responsible for support to LoB and Quality and introducing new processes and analytical methods into the commercial operations space.
- Reporting into the Team Lead SME s the Subject Matter Expert Biophysical Analysis oversees all biophysical characterization efforts from a scientific perspective and is able to translate current thinking and new advances into our analytical portfolio.
- In that role the person establishes and maintains an internal and external network of biophysical experts.
- Furthermore he or she indirectly guides all biophysical related activities in the department and provides significant input into regulatory documents and response to questions. This position does not have direct reports.
Roles and responsibilities include:
Scientific and Technical leadership (60% of average time spent)
- Analytical SME, with deep scientific understanding of biophysical methods (CD, FTIR, Fluorescence spectroscopy, DSC, SEC-MALLS, AUC, DLS, MFI) used for characterizing biotechnological products, e.g. protein structure, protein aggregates and particulates;
- Responsible for best scientific practices within the lab space and supports from an extended characterization perspective troubleshooting, process support and life cycle management activities;
- Writes complex technical documentation used for regulatory filings (e.g. Justification of specifications, process characterization summaries);
- Recruitment and supervision of MSc-level students.
Project leadership (40% of average time spent)
- Participates in cross-functional/global CMC project teams and leads derived sub-teams (e.g. working groups responsible for analytical or drug substance development work-streams);
- Participates as SME in solving technical problems at an international level;
- Root Cause Analysis lead for significant investigations (regional).
Desired skills & experience
- PhD in biological sciences, biochemistry, or biochemical engineering or equivalent through experience;
- Minimum of 5-10 years relevant experience in protein analytics;
- Significant experience in analytical methodologies for quality control of biotechnological products;
- Strong project management skills & proven ability to manage complex projects;
- Knowledge of regulatory and quality guidelines, and knowledge on CTD format for IND/ BLA/ MAA submissions preferred;
- Excellent analytical and technical skills;
- Demonstrated initiative, and innovative process-oriented thinking within a team environment;
- Excellent oral and written communication skills in English (Dutch is a plus).
- Our company is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
A good place to work
- Our company is an attractive employer offering interesting opportunities in Research & Development, production and staff departments for an enormous range of disciplines such as biologists, chemists, process engineers, technicians, mechatronic engineers, pharmacists and operators.
- Our company always seeks best-in-class employees at all levels.
- We expect a lot from our people and company has a lot to offer them as well.
- Team spirit, entrepreneurship, integrity, leadership and cross-border communication skills are what company values and rewards most.
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